ACLU Files Suit Against Gene Patents

American_Civil_Liberties_Union_logoLast week, the ACLU and a number of other groups filed suit against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to invalidate patents on human genes linked to breast and ovarian cancers.  The lawsuits allege that the patents are invalid as violating the right to free speech under the First and Fourteenth Amendments to the Constitution.

As you might expect, the ACLU issued a number of statements to the press on the lawsuit:

“Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights,” said ACLU Executive Director Anthony D. Romero. “The government should not be granting private entities control over something as personal and basic to who we are as our genes.”

“It is absolutely our intent that upon victory this will rend invalid patents on many other genes,” said Dan Ravicher, executive director of the Public Patent Foundation and a patent law professor at Yeshiva University’s Benjamin N. Cardozo School of Law. “We just had to pick one case as our case.”

The ACLU would have you believe that patents are being granted that cover the naturally occurring genes in the human body.  This is obviously not the case because such patents would not be novel or non-obvious (human genes have been around for many years).  Instead, the patents cover novel methods of detecting, screening, isolating such genes, and isolated, altered versions of the genes.

This means that the medical research that is being done to develop cures for diseases, such as breast and ovarian cancer, has led to many new discoveries for which patents have been granted.  The ACLU lawsuit alleges that such patents stifle innovation and keep further research from proceeding.  Most advocates of IP rights would argue, however, that such discoveries and cures would not be disclosed to the public without the patent grant.  Indeed, such discoveries may not take place at all.  Instead of stifling free speech, as the ACLU alleges, patents actually promote a public flow of information that would otherwise be kept secret by those making the discoveries (if they even make them at all).

Gene Quinn of IP Watchdog has an excellent analysis of the issues of the case including the complaint and the patents involved.  He characterizes the suit as frivolous, which I agree with.  He attributes this to a lack of understanding of patents on the part of the ACLU.  In general, I do not agree with this part of his opinion.  The Public Patent Foundation of the Benjamin Cardozo Law School is representing the plaintiffs in the case.

Instead, I believe that the purpose of the lawsuit is to misinform and inflame the public as to the issues of the case.  This is yet another attempt to scare the public into believing that patents are bad and that patents on medical research are especially bad.

This is similar to the February 2007 New York Times editorial by the late Michael Crichton where he argued that people are going to die because the PTO is granting patents on human genes.  Crichton argued that “one-fifth of the genes in your body are privately owned.”  Medical research companies own not only your genes, but also the pathogens that lead to many common illnesses.  Therefore, you can’t get treatment or testing for such illnesses unless you pay exorbitant royalties to the research company, if at all.

Like Crichton’s editorial, the ACLU seeks to get headlines from this suit.  On that front, they are succeeding.  It is highly unlikely that any of the patents in this suit will be invalidated and, if they are, it certainly won’t be because they are unconstitutional.  Let’s tone down the inflammatory rhetoric on patents and try to educate the public on what they are actually all about.

About these ads

6 Responses to “ACLU Files Suit Against Gene Patents”

  1. David Koepsell Says:

    You haven’t really looked into the issue, apparently. One of the claims on Myriad’s patents, and thousands of others, is for the gene sequence itself. Now, the PTO has a requirement that the sequence be “isolated and purified” which simply means leaving out a few of the exons, but this is not inventive, nor is it non-obviou to anyone trained in the field. The sequence itself, which is the creation of nature, is prior art and is a bar to patentability.

    It is like saying that Plutonium is patentable because it must be isolated and purified from Uranium.

    Not all of Myriad’s claims will be invalid, and they will still have protection on the test as a whole, but they won’t be able to bully researches studying breast cancer (as they have been) into shutting down their research or paying unnecessary royalties for doing basic science.

    • Matt Osenga Says:

      David,

      I appreciate your comment on this issue. You argue that an isolated, purified form of a gene should not be patentable even though that isolated and purified form of the gene does not naturally occur in nature because it would have been obvious to one of ordinary skill in the art in light of the naturally occurring non-purified, non-isolated form of the gene.

      I admit that I am not a geneticist and thus not one of ordinary skill in the art. What I do know is that this issue would surely have been raised in the Patent Office during prosecution of any patents claiming these isolated, purified genes. The Patent Office obviously disagreed with your position in these applications.

      The plaintiffs in this case (assuming they all have standing to do so) are free to raise this issue in court. They can certainly argue that the isolated, purified gene claims should be invalidated as being obvious to those of ordinary skill in the art. And perhaps the claims are obvious.

      My point, however, is that this is not the approach being taken by the ACLU and other plaintiffs. The approach they have chosen to take is to inflame the public by calling such patents unconstitutional and violative of basic human rights. Their goal here is not to win these cases in Federal court, but to instead win these cases in the court of public opinion by using misinformation and inflammatory rhetoric regarding the patent system.

      Matt

  2. David Koepsell Says:

    It isn’t the first time that the PTO got something wrong, and it sure won’t be the last, but it’s good that someone is finally trying to get it set straight. There’s also been a bill stalled in Congress for years trying to set it straight, but you can imagine to political pressure to keep it from passing.

    The sequence is found in nature, also. It’s like the Devil’s Tower, from the iconic scene in Close Encounters. There’s no natural boundary around it, so when we make maps or other ways to find it we must make boundaries. It’s the same type of “isolation and purification” that is being done with genes. It’s not inventive. Don’t worry, though, they can still patent the test itself without patenting the gene sequence. That’s what ought to have been in the first place.

  3. Jim Finder Says:

    Interesting discussion. But what’s the connection with Devil’s Tower? Seems like a non sequitur.

  4. David Koepsell Says:

    Devil’s Tower and the human breast cancer gene are both products of nature rather than human inventions (although both have been “discovered” by humans.

  5. Supreme Court to Review Myriad Case Again « INVENTIVE STEP Says:

    [...] The ACLU and other plaintiffs sued Myriad and the USPTO in 2009 claiming that Myriad’s patents to isolated genes are invalid as directed to non-statutory subject matter and in violation of the First Amendment to the Constitution.  In early 2010, the district court agreed that the gene patent claims were invalid under § 101 of the Patent Act, but not under the First Amendment. [...]

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s


Follow

Get every new post delivered to your Inbox.

Join 63 other followers

%d bloggers like this: